MAUDE Adverse Event Report: COOK MEDICAL NEEDLE'S EYE SNARE RETRIEVAL SET - 54CM; CATHETER, EMBOLECTOMY

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Type  Death  

Event Description

In accordance with title 21 part 803, subpart b, 803.22{b)(2), this letter is to notify and provide you the information spectranetics (a division of philips) received on 8 june 2018 related to an alleged adverse event resulting in a patient death.Although spectranetics devices were also in use during the patient procedure, spectranetics is not the manufacturer nor importer of the suspect device.A cook 20 mm needles eye snare was reportedly in use when the patient injury was detected.Please see attached details as were reported: the two leads being removed were located in the right atrium (ra) and the right ventricle {rv).Both leads were implanted (b)(6) 2006, and were being removed due to mrsa bacteremia infection.There was difficulty encountered in the innominate/svc junction due to visibly apparent calcium tissue, which was attempted by using multiple tools.The leads were prepped with lld ez locking stylets.Started with attempted removal of the rv lead with a 14fr glidelight and 33cm visisheath.Met stalled progession and switched to the ra lead, also encountering stalled progression at the same innominate/svc area.An llf tightrail mini device was then used with stalled progress on rv lead and then switched to ra lead with stalled progress.Then a 13f tightrail sub c device was used with stalled progress on the rv lead, but was successful at removing the ra lead.A 13f tightrail was attempted to attempt to get better coaxial alignment on the rv lead.This attempt was unsuccessful, so a decision was made to attempt femoral snaring to gain a better angle on the lead.A 20mm needles eye snare was used successfully from the right groin.He successfully snared the rv lead and pulled down and had his assistant hold traction, which he reattempted the 13f tightrail.This was unsuccessful, so he wanted to try a 16f glidelight device to see if that would help.After an unsuccessful attempt to remove the rv lead, the physician decided he would fully commit to removing the lead from below.He pulled on the lead from below and the rv lead tip came free first.He was able to entrap the distal tip of the rv lead into the femoral sheath and work the sheath up into the svc to give supportive traction, which successfully removed the lead in its entirety.A small pericardial effusion was detected and watched closely, then the patient's blood pressure dropped.The decision was made to immediately perform a sternotomy.An rv apex injury was discovered, which couldn't be repaired without decompressing the heart by going on bypass machine.The physician described the injury as a 2 to 3mm perforation that was caused by the traction on the lead by snaring it free and not by the use of any spectranetics extraction tools.The area was repaired using a pledget to seal the small hole while on bypass pump circulation.The patient survived the rescue and was extubated the following day.However her condition was critical due to her overall health and patient comorbidities.The patient expired on (b)(6) 2018.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE'S EYE SNARE RETRIEVAL SET - 54CM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 17533444
• MDR Text Key: 321043310
• Report Number: MW5140348
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1